Various surgical drain designs have previously been used to drain body cavities in connection with surgical procedures, and various methods of emplacing the drain tubing have been practiced in the past. Drain tubes are generally formed with a first imperforate hollow section and a second perforated hollow section having spaced drain holes that extend through its walls. It is known in the prior art to use a solid sharpened rigid rod or trocar sealed partially within and to an imperforate end of a tube or catheter to position a drain tube within a body cavity, such as shown in U.S. Pat. No. 4,883,474 to Sheridan. The trocar is swaged or press fit into the hollow tube to form an integral connection therewith.
After insertion into the body, the trocar with the imperforate section of tubing is passed from the body cavity through the body wall to a position wherein the rod or trocar and a portion of the imperforate section extend away a distance from the body and the perforated section remains inside the body wall. The outwardly extending portion of the imperforate section of tube is then severed at a location near the trocar and the severed trocar is disposed of. The resulting imperforate section of tube (or catheter) is then secured to an appropriate additional vacuum drain device to complete assembly of the suction type drain device.
Alternatively, use of a sharpened hardened plastic end on a flexible catheter tube, to permit body penetration by the hardened end, is illustrated in Sheridan U.S. Pat. No. 4,883,474. Once body penetration is achieved by this device, the hardened sharp end is severed to permit the catheter tube to be connected to a suction drain device by use of an additional structure.
A catheter having a plurality of drain openings for use within body openings is illustrated in U.S. Pat. No. 4,801,297 to Mueller, which discloses a multitude of radially spaced, axially aligned slits and spaced round perforations that extend through the catheter wall. U.S. Pat. No. 3,633,585 to McDonald, Jr., U.S. Pat. No. 3,854,477 to Smith, and U.S. Pat. No. 3,680,562 to Wittes, et al also teach the use of spaced round holes that extend through the catheter walls.
Several techniques have been utilized to achieve the mounting of drain catheters to solid metallic trocars or other similar devices to enable body wall penetration including bonding with resins or swaging, as disclosed in U.S. Pat. No. 3,680,562 to Wittes, et al., or U.S. Pat. No. 2,665,689 to Butler. It is also known to join silicone or plastic tubing over a smooth metal element by selecting a diameter for the plastic tubing that is capable of a degree of classic expansion to enable it to slide over the metal tubing to form a relatively firm connection.
Prior to the present invention, the positioning of a perforated section of a drain device or catheter within a patient's body, while having an imperforate extension of the catheter connected to an external drain system, involved in the steps of sealing a heavy metal cutting tool or trocar partly within the imperforated end of a flexible catheter or drain device, inserting a heavy metal cutting tool and catheter into a surgical opening, puncturing the body cavity wall to move the cutting tool and a portion of the imperforate section to a position extending outside of the body, severing and discarding the end of the catheter or drain device containing the heavy metal cutting tool, assembling an additional separate connecting device to the imperforate end of the catheter or drain device and then joining the connecting device to a suction unit.
The emplacement of existing surgical drain systems requires numerous steps, including the use of a separate device in addition to the drain device, the removal of the cutting device from the drain and then coupling the altered drain to a hollow connecting device. The additional structure and number of steps required by existing systems, to accomplish the same end result, likewise increase the risk of accidental puncture by contaminated sharpened devices as well as increasing the cost of the drain unit. The use of a heavy metal cutting tool, trocar or similar device, to form a perforation through the body cavity wall of a much larger diameter than the diameter of the catheter, creates an additional opening, of a size considerably larger than the diameter of the drain tubing itself, through the body wall, in the area of the surgical procedure. This, in effect, is an unnecessary size opening since in existing devices, the trocar has no function other than perforating the body, and is subsequently removed and discarded.